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Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic

Risk Factors and Outcomes of Acute Venous Thromboembolism in Cirrhotic Patients: A Hospital Based Prospective Study

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03580577
Enrollment
60
Registered
2018-07-09
Start date
2018-09-01
Completion date
2019-09-01
Last updated
2018-07-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver Cirrhosis, Venous Thromboembolism

Brief summary

patient with liver cirrhosis was supposed to have autoanticoagulation which approved to be wrong, with absence of conventional method to detect all abnormalities in coagulation state. Thromboelastography (TEG) give a broad picture for the coagulation defects. In addition to that no guidelines prescribed anticoagulants for venous thromboembolism in cirrhotic, so the investigators will do a study to demonstrate frequency and risk factors for acute venous thromboembolism in cirrhotic patients, find a conventional laboratory method and test TEG to assess risk of thrombosis in cirrhotic patients.Also, to validate current algorithm for use of anticoagulant and antiplatelet for thromboembolism for non cirrhotic in cirrhotic patients.

Detailed description

Nowadays, the term autoanticoagulated ,which prescribed coagulopathy state in chronic liver disease (CLD) patients due to impaired synthesis of coagulation factors and elevated international normalized ratio(INR), has been approved to be wrong and those patients are liable for venous thromboembolism (VTE) with 0.5% - 6.3% incidence of deep venous thrombosis (DVT) and pulmonary thromboembolism (PE) among cirrhotic patients. This may be explained by normal or even increased production of factor VIII and von Willebrand factor, enhanced thrombin activity and Low level of protein C, protein S and antithrombin III due to impaired liver synthesis, other risk factor include sedentary lifestyle, fractures, immobility, hospitalization, elevated estrogen levels, surgery, concomitant disease states and cancer, damaged vasculature that increases inflammation, and sluggish splanchnic blood flow, which are all common in those patients. Absence of gold standard estimation for hypercoagulability in cirrhotic patients, is a big problem. During measurement of conventional parameters such as international normalized ratio (INR) or partial thromboplastin time, reagents used to measure the prothrombin time do not contain thrombomodulin on which protein C depend for activation, so it does not adequately reflect reduced levels protein C. Thromboelastography a device that has the ability to measure whole blood coagulation cascade including platelet function, It can be used to monitor coagulation status before liver transplantation operation to properly identify and treat coagulation abnormalities. No worldwide guidelines is established neither for management nor prophylaxis of VTE in cirrhotic patients, this may be due to safety concerns regarding the risk of bleeding related to anticoagulant drugs when used in people with advanced liver disease, especially if there is significant thrombocytopenia, and/or the presence of varices.

Interventions

thromboelastography will assess all coagulation abnormalities including platelets function in cirrhotic group with venous thromboembolism , and guide us about is there increased thrombosis risk or not, for that a fresh blood sample will be withdrawn from each patient before starting any treatment

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* all cirrhotic patient who developed venous thromboembolic events * written informed consent (patient or nearest relative )

Exclusion criteria

* Patient with chronic thromboembolic event ( e.g. chronic pulmonary embolism, chronic portal vein thrombosis). * patients on antiplatelets or anticoagulants. * Patients with end stage kidney, heart or lung diseases * Pregnant. * Cirrhotic patients on control group who develop an acute thromboembolic event during the study period will be excluded and shifted to the case group

Design outcomes

Primary

MeasureTime frameDescription
Occurence of recanalization of thrombosed vessel24 weeks from baselineEfficacy of anticoagulants describe its ability to prevent further thrombosis and restore patency of thrmobosed vessel

Secondary

MeasureTime frameDescription
detect safety of anticoagulants in cirrhoticDuring treatment period wither 12 or 24 weeks from starting therapyOccurrence of any bleeding event while on anticoagulants therapy
Correlate thromboelastography results with hypercoagluable state in cirrhotic patients with venous thromboembolism1 dayChanges in r, k and MA- TEG parameters in cirrhotic patients with venous thromboembolism

Countries

Egypt

Contacts

Primary ContactAhmed Radwan Riad
dr.radwan1988@gmail.com+2 01126435001
Backup ContactMohamed Abdel Sabour Mohamed Mekky
mmekky75@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026